• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Salagen is and what it is used for
2. What you need to know before you take Salagen
3. How to take Salagen
4. Possible side effects
5. How to store Salagen
6. Contents of the pack and other information

• if you have been given radiotherapy for cancer of the head or neck, and your mouth feels very dry
• if you have been diagnosed with a condition called Sjögren’s syndrome, and your mouth and/or your eyes are dry

If you have any questions about how Salagen works or why this medicine has been prescribed for you, ask your doctor.

• if you are allergic to pilocarpine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have uncontrolled asthma.
• if you have uncontrolled heart or kidney disease.
• if you have a chronic disease which can worsen because of treatment with a medicinal product that acts like Salagen. Talk to your doctor if you are not sure.
• if you have any disorder in which you are to avoid constriction of the pupil of the eye (e.g., an acute inflammation of the iris of the eye).

If any of these apply to you, tell your doctor before taking Salagen.

Talk to your doctor or pharmacist before taking Salagen.

Tell your doctor before you take Salagen if you have any:

• lung problems (e.g. asthma, chronic bronchitis and/or chronic obstructive pulmonary disease)
• serious heart problems (e.g. heart failure, irregular pulse)
• gallbladder or bile duct problems (e.g. gallstones)
• stomach or intestinal problems (e.g. ulcers)
• cognitive problems (difficulties in learning, memory, perception, and problem solving) or mental problems
• kidney problems (e.g. renal insufficiency or kidney stones)
• eye problems (e.g. narrow-angle glaucoma)

Eye tests

Your doctor may want to check your eyes before you start the therapy. If you have not had your eyes checked recently, tell your doctor.

Excessive sweating

If you sweat excessively during Salagen treatment, drink more liquids. If you cannot drink enough liquids, contact your doctor as you may suffer from dehydration and organ damage if this continues.

This medicine should not be given to children or adolescents younger than 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to tell your doctor if you are taking any of the following:

• beta blockers (medicines used to treat high blood pressure, heart problems or eye problems)
• medicines for diarrhoea (e.g. atropine)
• medicines for asthma (e.g. ipratropium inhaler)
• medicines that activate so-called parasympathetic nervous system (e.g. some medicines for glaucoma, nervous system or mental diseases, Alzheimer’s disease, or medicines used to speed up gastric on intestinal passage)
• medicines that are broken down by a liver enzyme called CYP2A6, e.g., blood pressure lowering medicine irbesartan or medicines to prevent blood clotting (warfarin, dicoumarol).

If you are not sure if any of your medicines belong to this list, ask your doctor or pharmacist.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not use Salagen during pregnancy unless your doctor has recommended it. If you are a woman of childbearing potential, you should use an effective contraception to prevent pregnancy while taking this medicine. Ask your doctor for advice.

Breast-feeding

It is not known whether pilocarpine passes into human milk. Your doctor will tell you whether you should stop the treatment with Salagen or breast-feeding.

Fertility

This medicine may impair fertility in men and women. If you are planning to father a child, ask your doctor for advice before taking this medicine.

Salagen may cause dizziness or affect your vision, in particular, you may have problems seeing well at night. If this happens to you, do not drive or use any tools or machines.

• For patients who have been treated with radiotherapy for head and neck cancer:
  The recommended starting dose for adults is one 5 mg tablet three times a day.
  Make sure you take your last tablet of the day with your evening meal.
• For patients who have been diagnosed with Sjögren’s syndrome:
  The recommended dose for adults is one 5 mg tablet four times a day.
  Make sure that you take your last tablet of the day just before you go to bed.

Depending on how you respond to treatment, your doctor may suggest a higher or lower dose. The dose can be increased up to 30 mg (6 tablets) a day.

If you have cirrhosis (liver disorder), your doctor will start your treatment at a lower daily dose. Depending on how you respond to treatment, your doctor may gradually increase your dose up to the recommended daily dose.

Salagen should only be taken by mouth. Do not chew or bite the tablets.

Take Salagen tablets with a glass of water during or directly after meals.

Try to take your tablets at intervals spread out evenly over the day, e.g. take your first tablet in the morning, one in the afternoon and one in the evening.

Your doctor will tell you exactly how long you will need to take the tablets. If no improvement is noted after 2-3 months your doctor may decide to discontinue therapy.

If you have accidentally taken too many Salagen tablets, talk to a doctor immediately. You may require medical attention or even urgent hospital admission.

Overdose symptoms may include stomach cramps, diarrhea, nausea and vomiting, unwanted passage of stool and urine, sweating, salivation, increased secretion from the bronchi, shrinking of eye pupil, slow heartbeat, low blood pressure, muscle spasms or twitching, general weakness.

Do not take a double dose to make up for a forgotten tablet.

Do not stop taking your medicine unless your doctor tells you to.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is pilocarpine hydrochloride. Each Salagen 5 mg film-coated tablet contains 5 mg of pilocarpine hydrochloride.
• The other ingredients are cellulose microcrystalline and stearic acid. The coating is composed of Opadry white OY-7300 (containing hypromellose, macrogol 400 and titanium dioxide [E171]) and carnauba wax.

Salagen tablets for oral use are white, round biconvex tablets, marked “SAL” on one side and “5 mg” on the other side.

The tablets are packed in blisters and supplied in cartons containing 14, 21, 28 or 84 tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Manufacturer

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:

Austria, Finland, Germany, Italy, Netherlands, Spain, Sweden, Portugal, United Kingdom (Northern Ireland): SALAGEN